News You Might Have Missed: March 7th, 2023

The article News You Might Have Missed: March 7th, 2023 was originally published on Microdose.

Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed. It was a busy week with lots of news, have a look and see you next week for another update.


atai Life Sciences Announces Clinical Pipeline and Corporate Updates

It’s been a volatile few months for atai Life Sciences. The psychedelic juggernaut’s much-anticipated Phase 2 results for its most advanced program — PCN-101 (R-ketamine) — did not meet expected trial endpoints. The stock took a beating as investors re-assessed expectations.

The future of PCN-101 has been the big lingering question, as well as which other trials might take the lead going forward. Today we got some clarity, as atai released a pipeline update.



GH Research Reports Full Year 2022 Financial Results and Provides Business Updates

GH Research provided an update to its pipeline and business activities, including:

  • Recently initiated our multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). GH001 is a proprietary inhalable mebufotenin (5-MeO-DMT) product candidate.
  • In January 2023, reported development progress in respect of our proprietary aerosol delivery device and our expectation that we will submit an IND for GH001, delivered with this proprietary device, in the third quarter of 2023. 
  • We also reported the recent initiation of our randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002 in healthy volunteers (GH002-HV-105). GH002 is a mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach. We expect to complete this trial in the fourth quarter of 2023.



COMPASS Pathways Announces Fourth Quarter and Year-End 2022 Financial Results and Business Highlights

Compass has reported its financial results for the fourth quarter and year-end 2022 and gave an update on recent progress across its business. Highlights include:

  • Phase 3 pivotal program underway – important updates announced
  • Phase 3 long term follow up defined
  • Cash position at 31 December 2022 of $143.2 million



PharmAla Biotech named Exclusive MDMA Supply Partner to Awakn Life Sciences

“We’ve been working with the Awakn team for several months now, to ensure they have all the material needed for their development efforts,” said Nick Kadysh, CEO of PharmAla. 

“Awakn and PharmAla share a bit of founding history – Prof. David Nutt, who was a founding board member of PharmAla, left our board in order to take on the role of Chief Research Officer of Awakn. We think it’s completely fitting that we are able to supply Awakn with both engineering-grade and GMP LaNeo MDMA, which will grow their development program. I look forward to continued collaboration with Anthony and the Awakn team.”




PharmaDrug Collaborates with PharmaTher for Development of DMT Transdermal Patch

Daniel Cohen, CEO and Chairman of PharmaDrug, commented, “We are excited to commence a collaboration with PharmaTher, a leader in microneedle patch delivery of psychedelics. We believe our combined programs and expertise in drug delivery and pharmacology, specifically relating to DMT, set the stage for the potential development of new treatment options for mental health conditions.”


Want to catch up on more industry news? Check out a previous edition of the News You Might Have Missed


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